Versican Plus P - mri.cts-mrp.eumri.cts-mrp.eu/Veterinary/Downloads/DE_V_0265_001_PAR.pdfآ  Zoetis...

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    Beurteilungsbericht zur Veröffentlichung

    (gemäß § 31 Abs. 2 Tierimpfstoff-Verordnung)

    Versican Plus P

    Zulassungsdatum: 24.03.2016

    Zulassungsnummer: PEI.V.11781.01.1

    Datum der Erstellung des öffentlichen Beurteilungsberichts: 27 April 2017

    Datum der Bekanntgabe beim Antragsteller der/des Zulassungsänderung/Widerrufs, Rücknahme, Anordnung des

    Ruhens der Zulassung:

    -

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    Paul-Ehrlich-Institut Bundesinstitut für Impfstoffe und biomedizinische Arzneimittel Federal Institute for Vaccines and Biomedicines

    PAUL-EHRLICH-INSTITUT

    PAUL-EHRLICH-STRASSE 51-59

    63225 LANGEN Germany

    (Reference Member State)

    DECENTRALISED PROCEDURE

    PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY

    MEDICINAL PRODUCT

    Versican Plus P

  • Zoetis Belgium s.a. DE/V/0265/001/DC Application for Decentralised Procedure Publicly available assessment report

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    PRODUCT SUMMARY

    EU Procedure number DE/V/0265/001/DC

    Name, strength and pharmaceutical form

    Versican Plus P, lyophilisate and solvent for suspension for injection

    Applicant Zoetis Belgium s.a.

    Rue Laid Burnait, 1 1348 Louvain-la-Neuve Belgium

    Active substance(s) Each dose of 1 ml contains: Lyophilisate (live attenuated): Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 104.3 – 106.6 TCID50* Solvent: Water for injections (Aqua ad iniectabilia): 1 ml * Tissue culture infectious dose 50%

    ATC Vetcode QI07AD01

    Target species Dogs

    Indication for use Active immunisation of dogs from 6 weeks of age:

    - to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus.

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    SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE VETERINARY MEDICINAL PRODUCT

    Versican Plus P lyophilisate and solvent for suspension for injection for dogs 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each dose of 1ml contains: Active substances: Lyophilisate (live attenuated): Minimum Maximum

    Canine parvovirus Type 2b, strain CPV-2b Bio 12/B 104.3 TCID50* 106.6 TCID50 Solvent:

    Water for injections (Aqua ad iniectabilia) 1 ml * Tissue culture infectious dose 50%

    For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM

    Lyophilisate and solvent for suspension for injection. The visual appearance is as follows: Lyophilisate: spongy matter of white colour. Solvent: clear colourless liquid. 4. CLINICAL PARTICULARS 4.1 Target species

    Dogs 4.2 Indications for use, specifying the target species

    Active immunisation of dogs from 6 weeks of age:

     to prevent clinical signs, leucopoenia and viral excretion caused by canine parvovirus.

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    Onset of immunity:

     3 weeks after the first vaccination Duration of immunity: At least three years following the primary vaccination course 4.3 Contraindications

    None. 4.4 Special warnings for each target species

    A good immune response is reliant on a fully competent immune system. Immunocompetence of the animal may be compromised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. Immunological responses to CPV may be delayed due to maternally derived antibody interference. However, the vaccine has been proven to be protective against virulent challenge in the presence of maternally derived antibodies to CPV at levels equal or higher to those likely to be encountered under field conditions. In situations where very high maternally derived antibody levels are expected, the vaccination protocol should be planned accordingly. 4.5 Special precautions for use

    Special precautions for use in animals Vaccinate healthy animals only. The live attenuated virus vaccine strain CPV-2b may be shed by vaccinated dogs following vaccination, shedding of CPV has been shown for up to 10 days. However, due to the low pathogenicity of this strain, it is not necessary to keep vaccinated dogs separated from non-vaccinated dogs and domestic cats. The vaccine virus strain CPV-2b has not been tested in other carnivores (except dogs and domestic cats) that are known to be susceptible to canine parvoviruses and therefore vaccinated dogs should be separated from them after vaccination. Special precautions to be taken by the person administering the veterinary medicinal product to animals In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

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    4.6 Adverse reactions (frequency and seriousness)

    Following subcutaneous administration in dogs a transient swelling (up to 5 cm) may commonly be observed at the injection site. These can occasionally be painful, warm or reddened. Any such swelling will either have spontaneously resolved or be greatly diminished by 14 days after vaccination. In rare cases gastrointestinal signs such as diarrhoea and vomiting or anorexia and decreased activity are possible. As with any vaccine, in rare cases hypersensitivity reactions (i.e. anaphylaxis, angioedema, dyspnoea, circulatory shock, collapse) may occur. If such a reaction occurs, appropriate treatment should be administered without delay. The frequency of adverse reactions is defined using the following convention:

     very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)

     common (more than 1 but less than 10 animals in 100 animals)

     uncommon (more than 1 but less than 10 animals in 1,000 animals)

     rare (more than 1 but less than 10 animals in 10,000 animals)

     very rare (less than 1 animal in 10,000 animals, including isolated reports). 4.7 Use during pregnancy, lactation or lay

    The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Therefore the use is not recommended during pregnancy and lactation. 4.8 Interaction with other medicinal products and other forms of interaction

    No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product other than Versiguard Rabies and Versican Plus L4. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis by the veterinarian. 4.9 Amounts to be administered and administration route

    Subcutaneous use. Dosage and route of administration: Aseptically reconstitute the lyophilisate with the solvent. Shake well and administer immediately the entire contents (1 ml) of the reconstituted product.

    Reconstituted vaccine: Whitish to yellowish colour with light opalescence.

    Primary vaccination scheme: Two doses of Versican Plus P 3–4 weeks apart from 6 weeks of age.

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    Leptospira: If protection against Leptospira is required, dogs can be vaccinated with two doses of Versican Plus P mixed with Versican Plus L4 3–4 weeks apart from 6 weeks of age: The contents of a single vial of Versican Plus P should be reconstituted with the contents of a single vial of Versican Plus L4 (instead of the solvent). Once mixed, the contents of the vial should appear a whitish to yellowish colour with a slight opalescence. The mixed vaccines should be injected immediately via the subcutaneous route. Rabies: If protection against rabies is required: First dose: Versican Plus P from 8–9 weeks of age. Second dose: Versican Plus P mixed with Versiguard Rabies 3–4 weeks later, but not before 12 weeks of age. The contents of a single vial of Versican Plus P should be reconstituted with the contents of a single vial of Versiguard Rabies (instead of the solvent). Once mixed, the contents of the vial should appear a pink/red or yellowish colour with a slight opalescence. The mixed vaccines should be injected immediately via the subcutaneous route. The efficacy of the rabies fraction is proven after a single dose from 12 weeks of age in laboratory studies. However, in field studies 10% of seronegative dogs did not show seroconversion (>0.1 IU/ml) 3–4 weeks after single primary vaccination against rabies. Some animals may also not show titres > 0.5 IU/mL after the primary vaccination. Antibody titres drop over the course of the 3-year duration of immunity, although dogs are protect